D
Patient 1
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX? BIVONA? ADULT TTS? TRACHEOSTOMY TUBE WAS CHANGED OUT DUE TO A HOLE IN THE BALLOON. THERE WERE NO REPORTED ADVERSE EFFECTS.
MAUDE MDR 9908292
- MDR report key
- 9908292
- Report number
- 3012307300-2020-02648
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-02
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- DAVE HALVERSON
- Address
- 6000 NATHAN LANE N MINNEAPOLIS,, MN US
- Phone
- 383-383-3833
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PORTEX? BIVONA? ADULT TTS? TRACHEOSTOMY TUBES | TUBE TRACHEOSTOMY AND TUBE CUFF | SMITHS MEDICAL ASD; INC. | JOH | 670170 | 670170 | 3488067 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. R |